ACIDO 100 mg Enteric-Coated Tablet

Содержание инструкции

1. Acido Acetilsalicilico TecniGen 100 mg gastro-resistant tablets
   1. What is Acido Acetilsalicilico TecniGen and what is it used for
   2. What you need to know before taking Acido Acetilsalicilico TecniGen.
   3. How to take Acido Acetilsalicilico TecniGen
   4. Possible side effects
   5. How to store Acido Acetilsalicilico TecniGen
   6. Contents of the pack and other information

Acido Acetilsalicilico TecniGen 100 mg gastro-resistant tablets

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Acido Acetilsalicilico TecniGen is and what it is used for.
• 2. What you need to know before you take Acido Acetilsalicilico TecniGen.
• 3. How to take Acido Acetilsalicilico TecniGen.
• 4. Possible side effects.
• 5. How to store Acido Acetilsalicilico TecniGen.
• 6. Contents of the pack and other information.

1. What is Acido Acetilsalicilico TecniGen and what is it used for

Acido Acetilsalicilico TecniGen contains acetylsalicylic acid, which at low doses belongs to a group
of medicines called antiplatelet agents. Platelets are small blood cells that
cause coagulation and are involved in thrombosis. When a blood clot forms in
an artery, blood flow is blocked and the supply of oxygen is interrupted. When this occurs in the
heart, it can cause a heart attack or angina; in the brain it can cause a stroke.
Acido Acetilsalicilico TecniGen is taken to reduce the risk of blood clot formation and therefore
prevent the following:

• heart attacks;
• stroke;
• cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain).

Acido Acetilsalicilico TecniGen is also used to prevent the formation of blood clots after
some heart surgeries, performed to widen or unblock blood vessels.
This medicine is not recommended in emergency situations. It can only be used as a preventive
treatment.

2. What you need to know before taking Acido Acetilsalicilico TecniGen.

Do not take Acido Acetilsalicilico TecniGen:

• if you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain;
• if you have had an asthma attack or if some parts of your body, such as your face, lips, throat or tongue (angioedema) have swollen after taking salicylates or NSAIDs;
• if you have or have ever had a stomach or small intestine ulcer;
• if you have a history of gastrointestinal bleeding or perforation (gastric or intestinal failure) caused by previous therapy with NSAIDs;
• if you have a history of recurrent gastric and duodenal ulcer/bleeding with episodes of ulceration or

bleeding, or any other type of bleeding such as a stroke;

• if you have had problems with blood clotting;
• if you suffer from severe liver or kidney problems;
• if you have serious heart problems that can cause shortness of breath or swelling of the ankles;
• during the last 3 months of pregnancy; you should not take doses higher than 100 mg per day (see section “Pregnancy and breastfeeding”);
• if you are taking a medicine called methotrexate (for example for the treatment of cancer or rheumatoid arthritis) at doses higher than 15 mg per week.

Warnings and precautions
Talk to your doctor before taking Acido Acetilsalicilico TecniGen if:

• you have problems with your kidneys, liver or heart;
• you have or have had problems with your stomach or small intestine;
• you have high blood pressure;
• you are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid can cause an asthma attack;
• you have ever had gout;
• you have heavy menstrual periods;
• you suffer from a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme.

You should immediately see a doctor if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions or any other sign of a serious allergic reaction (see section “Possible side effects”).
Tell your doctor if you are going to have surgery (even a minor one, such as a tooth extraction). Acetylsalicylic acid makes the blood more fluid and therefore there may be an increased risk of bleeding.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) because the simultaneous use of acetylsalicylic acid can cause a deterioration of kidney function.
This medicine is not suitable as a pain reliever or to reduce fever.
If any of the above conditions apply to you, or if you have any doubts, consult your doctor or pharmacist.

Children and adolescents
Acetylsalicylic acid, if given to children, can cause Reye's syndrome. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, Acido Acetilsalicilico TecniGen should not be given to children and adolescents under the age of 16, unless advised by a doctor.

Other medicines and Acido Acetilsalicilico TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effectiveness of the treatment may be affected if acetylsalicylic acid is taken at the same time as other medicines for:

• thinning the blood/preventing blood clots (e.g. warfarin, heparin, clopidogrel, alteplase);
• organ transplant rejection (cyclosporine, tacrolimus);
• high blood pressure (e.g. diuretics and ACE inhibitors);
• regulating the heartbeat (digoxin);
• manic-depressive illness (lithium);
• pain and inflammation (e.g. NSAIDs (such as ibuprofen) or steroids);
• metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that join together and form a blood clot) if taken concurrently. Therefore, this combination should be used with caution in patients who

are taking low doses of acetylsalicylic acid for cardioprotection;

• gout (e.g. probenecid);
• epilepsy (valproate, phenytoin);
• glaucoma (acetazolamide);
• cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week);
• diabetes (e.g. glibenclamide, insulin);
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine);
• use as hormone replacement therapy after destruction or removal of the adrenal glands or pituitary gland, or to treat inflammation, including rheumatic diseases and inflammation of the intestine (corticosteroids).

Acido Acetilsalicilico TecniGen with food, drinks and alcohol
Drinking alcohol can increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by a doctor.
You should not take Acido Acetilsalicilico TecniGen in the last 3 months of pregnancy unless prescribed by your doctor and in this case the daily dose should not exceed 100 mg (see section “Do not take Acido Acetilsalicilico TecniGen”). Regular or high doses of this medicine during the last part of pregnancy can cause serious complications in the mother or the baby.
Women who are breastfeeding should not take acetylsalicylic acid unless they have been advised by their doctor.
Acetylsalicylic acid can affect female fertility through an effect on ovulation. This effect is reversible after stopping treatment.

Driving and using machines
Acido Acetilsalicilico TecniGen does not affect the ability to drive and use machines.

Acido Acetilsalicilico contains lactose.
If you have been told that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Acido Acetilsalicilico TecniGen

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once a day.

Prevention of strokes:

• The recommended dose is 100 mg once a day.

Prevention of cardiovascular problems in patients suffering from stable or unstable angina (a type of

chest pain):

• The recommended dose is 100 mg once a day.

Prevention of blood clot formation after some types of heart surgery:

• The recommended dose is 100 mg once a day.

This medicine should not be taken at doses higher than recommended by your doctor and the dose
should not exceed 300 mg per day.

Elderly patients
The recommended dose is the same as indicated for younger adults. In general, acetylsalicylic acid should be
used with caution in elderly patients who are more sensitive to adverse events. Treatment should be re-evaluated at
regular intervals.

Use in children and adolescents
Acetylsalicylic acid should not be administered to children and adolescents under 16 years of age, unless
prescribed by a doctor (see section “Warnings and precautions” “”).
Method of administration
Oral use.
The tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water). The
tablets have an enteric coating that prevents irritating effects on the intestine and therefore should not be
crushed, broken or chewed.

If you take more Acido Acetilsalicilico TecniGen than you should
If you (or anyone else) accidentally take too many tablets, you should immediately contact your
doctor or contact the nearest emergency room. Show the doctor what is left of the medicine or the
empty package.
Symptoms of overdose may include ringing in the ears, hearing problems, headache, dizziness,
confusion, nausea, vomiting, and abdominal pain. A considerable overdose can lead to rapid breathing
(hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, pulmonary edema,
low blood sugar levels, coma, and shock.

If you forget to take Acido Acetilsalicilico TecniGen
If you forget a dose, wait until the time to take the next dose, then proceed as usual.
Do not take a double dose to make up for the missed tablet.

If you stop taking Acido Acetilsalicilico TecniGen
Do not stop or suspend treatment with Acido Acetilsalicilico TecniGen without first agreeing
with your doctor.
If you have any doubts about the use of this product, please contact your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Acido
Acetilsalicilico TecniGen and tell your doctor immediately:

• Sudden wheezing, swelling of the lips, face or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling which may be associated with high fever and joint pain. This may be erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome.
• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

Other side effects:

• Common (may affect up to 1 in 10 people) Nausea, vomiting, diarrhoea.
• Indigestion.
• Increased tendency to bleed. Uncommon (may affect up to 1 in 100 people)
• Hives
• Runny nose.
• Difficulty breathing.

Rare (may affect up to 1 in 1000)

• Severe bleeding of the stomach or intestines, cerebral haemorrhage; altered number of blood cells.
• Cramps in the lower respiratory tract, asthma attacks.
• Inflammation of blood vessels.
• Bruising with purplish spots (skin bleeding).
• Severe skin reactions such as skin rash known as erythema multiforme and its life-threatening forms, Stevens-Johnson syndrome and Lyell's syndrome.
• Hypersensitivity reactions, such as swelling e.g. of the lips, face or body, or shock.
• Reye's syndrome (a very rare disease in children that affects the brain and liver) (see section 2 “Children and adolescents”).
• Very heavy or prolonged menstrual bleeding.

Not known (frequency cannot be estimated from available data)

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Impaired kidney function, acute renal failure.
• Impaired liver function, increased liver enzymes.
• High levels of uric acid or low levels of sugar in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Acido Acetilsalicilico TecniGen

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging or on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Acetilsalicilico TecniGen contains

• The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
• The other excipients are:
• Tablet core:lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica and potato starch.
• Gastro-resistant coating film:talc, triacetin and acrylic acid-ethyl acrylate copolymer.

Description of the appearance of Acido Acetilsalicilico TecniGen and contents of the pack
White, round, biconvex tablet with a diameter of approximately 8.1 mm and a thickness of approximately 3.5 mm.
Cardboard packaging with PVC/Al blisters containing 30 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Tecnigen S.r.l.
via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy.
Manufacturer
GLPharma GmbH
Industriestrasse 1, A-8502 Lannach
Austria.
GL Pharma GmbH
Schlossplatz 1, A-8502
Lannach
Austria.

This medicinal product is authorised in the Member States of the EEA with the following denominations: